Shijiazhuang, Hebei, China
NCT Number: NCT06828718
The Neoadjuvant Treatment Modalities in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (NEO-EC)
The prognosis and safety of patients with locally advanced esophageal squamous cell carcinoma were compared with different neoadjuvant therapy modes in multi-cancer centers in China
This study is active but is not currently recruiting participants.
Key information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
Neoadjuvant chemoradiotherapy or neoadjuvant chemotherapy combined with surgery are the main treatment methods for patients with locally advanced esophageal squamous cell carcinoma, but some patients still have local recurrence or distant metastasis after surgery. In the era of immunotherapy, immune checkpoint inhibitor monotherapy or combined chemotherapy has become the first-line and second-line standard treatment for recurrent or metastatic esophageal cancer and has been recommended by NCCN guidelines. However, relevant studies on immunotherapy's participation in neoadjuvant therapy have shown good results, but it is still in its initial stage, and its efficacy needs further research and discussion.Thus, we compared the prognosis and safety of patients with locally advanced esophageal squamous cell carcinoma who received different neoadjuvant therapy before surgery, including neoadjuvant chemoradiotherapy, neoadjuvant chemotherapy, neoadjuvant chemotherapy combined with immunotherapy, and neoadjuvant chemoradiotherapy combined with immunotherapy in several cancer centers in China.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age ≥18 years, male or female;
- KPS score (KPS) ≥70;
- Esophageal squamous cell carcinoma confirmed by histopathology;
- Clinical stage cT1b-4aN+M0,T3-4aN0M0;
- Surgical resection was performed after 2~4 cycles of neoadjuvant therapy.
- Expected survival > 6 months.
Exclusion criteria
- Have a history of other malignancies (except for cancer in situ that has been cured and other malignancies that have been cured for more than 5 years);
- There are contraindications of immunotherapy or chemoradiotherapy;
- Inability to tolerate or refuse surgery;
- Distant metastasis has occurred;
Treatment and study plan
Primary outcomes
-
Comparison of pathological complete response rate (pCR) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy
Time frame: 2015.1.1-2023.12.31
Pathological complete response (pCR) is defined as the absence of residual tumor cells after evaluation of removed tumor tissue and regional lymph nodes.
-
Comparison of major pathological response (MPR) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy
Time frame: 2015.1.1-2023.12.31
Major pathological response (MPR) is defined as a tumor that has significantly shrunk or decreased in the pathological evaluation, but still has a small number of residual tumor cells.
Secondary outcomes
-
Comparison of the overall survival (OS) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy
Time frame: 2015.1.1-2025.12.31
OS is defined as the time from the start of enrollment to death from any cause
-
Comparison of the disease-free survival (DFS) after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy
Time frame: 2015.1.1-2025.12.31
DFS difined as the time between the start of the enrollment and the recurrence of disease, or death from any cause.
Other outcomes
-
Comparison of incidence of treatment-related adverse evants after surgical resection in patients with locally advanced esophageal squamous cell carcinoma receiving different neoadjuvant therapy
Time frame: 2015.1.1-2025.12.31
Adverse events are observed during the course of the study and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE V5.0).
Sponsors and collaborators
Lead sponsor
Hebei Medical University Fourth Hospital
Other
Collaborators
- Fujian Cancer Hospital
- Jiangsu Cancer Institute & Hospital
- Shandong Cancer Hospital and Institute
- Shanxi Province Cancer Hospital
- Sichuan Cancer Hospital and Research Institute
- Tianjin Medical University Cancer Institute and Hospital
Registry information
Official study title
Comparison of the Prognosis and Safety of Different Neoadjuvant Treatment Modalities in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma: A National Multicenter Real-World Study(NEO-EC)
Acronym: NEO-EC
Important dates
- Study start
- 2015
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Feb 14, 2025
- Registry last updated
- Feb 14, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
NCT02465060
Adenocarcinoma, Adnexal Diseases
Birmingham, Alabama, United States
View Trial DetailsYoga Program for Improving the Quality of Life in Couples Coping With Cancer
NCT04607590
Digestive System Diseases, Digestive System Neoplasms
Houston, Texas, United States
View Trial DetailsDetermining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers
NCT07118176
Adenocarcinoma, Adnexal Diseases
Los Angeles, California, United States
View Trial DetailsVeliparib, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery and Liver or Kidney Dysfunction
NCT01366144
Adnexal Diseases, Breast Carcinoma
Duarte, California, United States
View Trial Details